ASTM-F703 › Historical Revision Information
Standard Specification for Implantable Breast Prostheses
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Scope
1.1 This specification covers the requirements for silicone gel-filled, saline inflatable silicone gel-filled, and saline inflatable, smooth-shell implantable breast prostheses intended for use in surgical reconstruction, augmentation, or replacement of the breast.
1.2 Limitations This specification does not cover custom fabricated implantable breast prostheses.
1.3 The values stated in SI units are to be regarded as the standard. The inch-pound units given in parentheses are for information only.
This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
Keywords
breast prosthesis; gel-saline prosthesis; implant; saline inflatable prosthesis; silicone elastomer; silicone gel prosthesis; soft tissue implant; ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
To find similar documents by ASTM Volume:
13.01 (Medical and Surgical Materials and Devices)
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Document Number
ASTM-F703-96(2002)e1
Revision Level
1996 R02(E1) EDITION
Status
Superseded
Modification Type
Editorially changed
Publication Date
June 1, 2006
Document Type
Specification
Page Count
9 pages
Committee Number
F04.32